Evaluation of a standardized treatment regimen of anti-tuberculosis drugs for patients with multi-drug-resistant tuberculosis (STREAM): study protocol for a randomized controlled trial.
Evaluation of a standardized treatment regimen of anti-tuberculosis drugs for patients with multi-drug-resistant tuberculosis (STREAM): study protocol for a randomized controlled trial.
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DOI：
10.1186/1745-6215-15-353
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发表时间：
2014-09-09
期刊：
影响因子：
2.5
通讯作者：
Meredith SK
中科院分区：
文献类型：
--
作者：
Nunn AJ;Rusen ID;Van Deun A;Torrea G;Phillips PP;Chiang CY;Squire SB;Madan J;Meredith SK
与对药物敏感的结核病相比，耐多药结核病的治疗指南证据基础非常薄弱;目前根据专家意见提出的建议是，患者至少应接受20个月的治疗。在孟加拉国进行的一系列队列研究确定了一种为期九个月的方案，取得了非常有希望的结果。有必要在一项随机对照试验中，在各种情况下（包括HIV合并感染患者）与目前推荐的方案进行比较，以评估该方案。STREAM是一项采用非劣效性设计的多中心随机试验，比较了9个月的治疗方案与世界卫生组织目前推荐的耐多药肺结核患者的治疗，在线探针检测没有氟喹诺酮或卡那霉素耐药性的证据。9个月的治疗方案包括氯法齐明和高剂量阿氟沙星，如果涂片转换延迟，可以延长至11个月。主要结局基于随机化后27个月患者的细菌学状态。基于9个月方案比对照方案略有效的假设，并且考虑到10%的非劣效性界值，共需要入组400例患者。正在收集选定地点所有患者的卫生经济学数据。孟加拉国的研究结果和其他地方正在进行的队列研究令人鼓舞，但要使这种方案比在研究环境中更广泛地推荐，还需要来自随机临床试验的有力证据。STREAM试验的结果以及正在进行的队列研究的数据应提供必要的证据，以修订目前对耐多药结核病治疗的建议。本试验于2010年10月14日在clincaltrials.gov上注册（注册号：ISRCTN 78372190）。
In contrast to drug-sensitive tuberculosis, the guidelines for the treatment of multi-drug-resistant tuberculosis (MDR-TB) have a very poor evidence base; current recommendations, based on expert opinion, are that patients should be treated for a minimum of 20 months. A series of cohort studies conducted in Bangladesh identified a nine-month regimen with very promising results. There is a need to evaluate this regimen in comparison with the currently recommended regimen in a randomized controlled trial in a variety of settings, including patients with HIV-coinfection. STREAM is a multi-centre randomized trial of non-inferiority design comparing a nine-month regimen to the treatment currently recommended by the World Health Organization in patients with MDR pulmonary TB with no evidence on line probe assay of fluoroquinolone or kanamycin resistance. The nine-month regimen includes clofazimine and high-dose moxifloxacin and can be extended to 11 months in the event of delay in smear conversion. The primary outcome is based on the bacteriological status of the patients at 27 months post-randomization. Based on the assumption that the nine-month regimen will be slightly more effective than the control regimen and, given a 10% margin of non-inferiority, a total of 400 patients are required to be enrolled. Health economics data are being collected on all patients in selected sites. The results from the study in Bangladesh and cohorts in progress elsewhere are encouraging, but for this regimen to be recommended more widely than in a research setting, robust evidence is needed from a randomized clinical trial. Results from the STREAM trial together with data from ongoing cohorts should provide the evidence necessary to revise current recommendations for the treatment for MDR-TB. This trial was registered with clincaltrials.gov (registration number: ISRCTN78372190) on 14 October 2010.
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